Forced Degradation

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FORCED DEGRADATION STUDY

Forced Degradation Study (or Stress Testing) typically involves ¹[the] Exposure of Drug Substances or Formulations thereof to Environmental Stress Conditions namely Heat and Humidity and Light for Solid-State Studies. For Liquid State Studies²[,] the Drug Substance/Formulation is exposed to a range of pH values, Freezing and Thawing. It is also referred as Accelerated Stability Study.

Degradation Type	Experimental Conditions	Condition
Acid	0.1 N Hydrochloric Acid	Ambient
Base	0.1 N NaOH	Ambient
Oxidation	3 % Hydrogen Peroxide	Ambient
Photolysis	UV Lamp	Ambient
Thermal	Heat Chamber	60°C
Metal Ions	0.05 M Fe2 or Cu2	Ambient
Humidity	Stability Chamber	75 % RH or Greater

Forced Degradation

In ICH Q1A, Section 2.1.2 (Stress Testing), there are recommended Conditions [Conditions have been recommended] for performing Forced Degradation Studies on Drug Substances (API) and Drug Products (Formulations).

In ICH Q1A, Section 2.1.2 (Stress Testing), ¹there are recommended Conditions [Conditions have been recommended] for performing Forced Degradation Studies on Drug Substances (API) and Drug Products (Formulations).

The Recommendations ²are to examine [for the examination of] the Effects of Temperature (above that for Accelerated Testing, i.e., >50°C), Humidity (≥75% Relative Humidity), Oxidation & Photolysis.

ICH Q1B ³gives recommended [recommends] approaches to assess the ⁴Photo stability [Photostability] of Drug Substances and Drug Products. Forced Degradation Conditions are specified in Section II (Drug Substance) and Section III (Drug Product). ⁵Photo stability [Photostability] Testing can be performed on the Solid or in Solution/ Suspension.

EFRAC has proven Competency and Adequate Capacity to undertake all such Degradation Studies across Various Drug Matrices. ⁶At EFRAC the [EFRACs] dedicated analytical team is equipped with the ⁷necessity [necessary] state-of-the-art facilities and technical expertise to ensure complete Drug safety for future generations.